SINGLE DOSE PANDEMIC INFLUENZA VACCINE July 2008 About IVT by akgame

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									                                                               SINGLE DOSE PANDEMIC INFLUENZA VACCINE
                                                                                              July 2008



                             About IVT Technology
                             • IVT is developing a SINGLE DOSE Pandemic Influenza vaccine
                             • IVT is a private biotechnology company focused on the commercialization of a proprietary
                                vaccine delivery and enhancement platforms, trade named VacciMax® and DepoVax™.
                             • IVT holds issued patents for its technology to be used with “any antigen and any
                                adjuvant, any liposome and any oil”.
                             • VacciMax® and DepoVax™ significantly enhance the speed and magnitude of antibody
                                and T-cell immune responses to “marginal” antigens with a SINGLE DOSE.
                             • The DepoVax™ technology, being a dry formulation, has the added benefit of enhanced
                                stability and ease of use.


                             Single Dose Pandemic Influenza Vaccine
For additional information
please contact:              In the event of an influenza pandemic, millions of people around the world will die in a
                             matter of months. Current pandemic flu vaccines in develop require two doses to achieve
Dr. Randal Chase             efficacy. Though a single dose vaccine would be much superior, technologies on the
President & CEO              market today are unable to support a single dose pandemic flu vaccine. IVT’s recent pre-
(902) 492-1819               clinical studies with a recombinant H5N1 hemagglutinin antigen formulated in the
rc.ivt@immunovaccine.com
                             VacciMax® platform have made a single dose pandemic flu vaccine a possibility. IVT has
Dr. Marc Mansour             recently repeated the studies using DepoVax™ formulations and showed that the results
VP R&D                       from the two formulations are equivalent.
(902) 421-5733
mm.ivt@immunovaccine.com     IVT is enthusiastic about the development of a single dose pandemic influenza product
                             based on our novel vaccine enhancement technology. IVT was one of two Canadian
Ella Korets-Smith
Director Business
                             companies invited to participate in the WHO Pandemic Influenza meeting in Geneva in
Development                  December 2007. At this meeting IVT introduced its study to show that a single dose of the
(902) 492-1819               H5N1 antigen incorporated in IVT’s enhancement technology formulation is able to raise an
eks.ivt@immunovaccine.com    immune response more quickly and effectively than two doses of the conventional
                             formulation.
ImmunoVaccine
Technologies Inc.
                             IVT is able to show strong immune responses at week 3 post vaccination, and has since
                             shown responses at 18 days post vaccination (Figure 1). The striking reduction in time to
1819 Granville Street,       antibody response is significant for the development of a single dose pandemic influenza
Suite 303                    vaccine. Furthermore, the antibody levels raised by a single dose of IVT’s vaccine are
Halifax, Nova Scotia,        maintained for the duration of the experiment and are at all times superior to a single dose
Canada B3J 3R1               of the control alum vaccine and in the longer term superior or equal to the two dose alum
www.immunovaccine.com
                             vaccine.
                                                                                                                                       1819 Granville Street, Suite 303
                                                                                                                               Halifax, Nova Scotia, Canada B3J 3R1
                                                                                                                                             0011 + 1 + 902-492-1819
                                                                                                                                            www.immunovaccine.com




                                                  6.75
                                                             Comparing One to One dose
                                                  6.50

                                                  6.25

                                                  6.00

                                                  5.75

                                                  5.50
                                    Log Titre




                                                  5.25

                                                  5.00

                                                  4.75

                                                  4.50

                                                  4.25

                                                  4.00                                 VacciMax-based vaccine
                                                                                       control alum vaccine
                                                  3.75

                                                  3.50
                                                         2          4       6                  8                     10        12              14
                                                                                    weeks post-vaccination


                                                  7.00
                                                             Comparing One to Two dose
                                                  6.75

                                                  6.50

                                                  6.25

                                                  6.00

                                                  5.75
                                      Log Titre




                                                  5.50

                                                  5.25

                                                  5.00

                                                  4.75

                                                  4.50

                                                  4.25
                                                                                    DepoVax-based vaccine
                                                  4.00                              control alum vaccine

                                                  3.75
                                                         2      4       6       8               10              12        14        16          18
                                                                                    weeks post-vaccination




                                  Figure 1: IVT’s single dose pandemic influenza vaccine is superior to a single dose or two
                                  doses (week 3 boost) of the control alum vaccine formulation. The response from the single
                                  dose is early and long lasting.


                                  In another experiment using the seasonal influenza antigens, VacciMax®-based influenza
                                  vaccines are able to stimulate active virus neutralizing antibodies in 100% of test animals for
                                  close to one year with a SINGLE DOSE. In contrast the response rate to the control
                                  commercial vaccine dropped to 60% after only 20 weeks. Virus neutralizing antibody titers
                                  in rabbits vaccinated with IVT’s seasonal influenza vaccine were found to be 4x-10x higher
                                  than in rabbits vaccinated with the control vaccine.

                                  The stimulation and maintenance of an enhanced level of neutralizing antibodies likely
                                  resulted in 100% response rate to IVT’s vaccine. This is significant in the context of a
                                  pandemic vaccine for which a low individual response rate could lead to many deaths in the
                                  event of a pandemic.

Do not duplicate or distribute without express permission of ImmunoVaccine Technologies Inc. (IVT)                                                                2
                                                                                                             1819 Granville Street, Suite 303
                                                                                                     Halifax, Nova Scotia, Canada B3J 3R1
                                                                                                                   0011 + 1 + 902-492-1819
                                                                                                                  www.immunovaccine.com



                                                                                                       UPDATE NEWSLETTER
                                                                                                                 April 2008




                                  Figure 2: IVT’s single dose seasonal influenza vaccine is able to raise 4-10X higher
                                  neutralizing antibody levels and maintain 100% responder rate for nearly 1 year.


                                  Continuing Work
                                  IVT is continuing the development of the Pandemic Influenza vaccine. The company is
                                  planning further immunogenicity studies in ferrets as well as challenge studies in mice and
                                  ferrets for the single dose vaccine. These studies will form the basis of the future IND
                                  application for the vaccine product candidate.


                                  IVT’s Keys to Success
                                  • IVT has completed manufacturing method development and scale-up for the VacciMax®
                                     and DepoVax™ platforms at an external cGMP contract development site using IVT
                                     owned equipment. IVT has manufactured commercial size batches (50L, 200,000
                                     doses) and showed that the large scale formulations retains the superior efficacy shown
                                     in the original proof of concept studies. The manufacturing methods are transferable
                                     and could be easily scaled up further.
                                  • IVT has developed all of the analytical methods required to analyze all components of the
                                     VacciMax® and DepoVax™ platforms. Stability studies conducted at storage and
                                     accelerated temperature conditions show that the basic platform is stable for at least
                                     eleven months with the studies extending up to two years.
                                  • IVT has begun its partnering efforts with licensing of the VacciMax® platform to Pfizer
                                     Animal Health.




Do not duplicate or distribute without express permission of ImmunoVaccine Technologies Inc. (IVT)                                      3
Do not duplicate or distribute without express permission of ImmunoVaccine Technologies Inc. (IVT)   4

								
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